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FDA 510(k)

Duette 100% Silicone Dual-Balloon, Temperature-Sensing Catheter

K-Number: K173533 · 2018-03-29

ApplicantPoiesis Medical, LLC
Decision Date2018-03-29
Product CodeEZL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Duette 100% Silicone Dual-Balloon, Temperature-Sensing Catheter is a medical device manufactured by Poiesis Medical, LLC. It received FDA 510(k) clearance on 2018-03-29 under approval number K173533. The device is classified under product code EZL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Duette 100% Silicone Dual-Balloon, Temperature-Sensing Catheter?

Duette 100% Silicone Dual-Balloon, Temperature-Sensing Catheter is a medical device that received FDA 510(k) clearance on 2018-03-29. It is manufactured by Poiesis Medical, LLC. The 510(k) number is K173533.

When was Duette 100% Silicone Dual-Balloon, Temperature-Sensing Catheter approved by the FDA?

Duette 100% Silicone Dual-Balloon, Temperature-Sensing Catheter received FDA 510(k) clearance on 2018-03-29, under approval number K173533.

What company makes Duette 100% Silicone Dual-Balloon, Temperature-Sensing Catheter?

Duette 100% Silicone Dual-Balloon, Temperature-Sensing Catheter is manufactured by Poiesis Medical, LLC.

What is the FDA product code for Duette 100% Silicone Dual-Balloon, Temperature-Sensing Catheter?

The FDA product code for Duette 100% Silicone Dual-Balloon, Temperature-Sensing Catheter is EZL.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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